Meher Bikash R, Mohanty Rashmi R, Dash Ashish
Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, IND.
General Medicine, All India Institute of Medical Sciences, Bhubaneswar, IND.
Cureus. 2024 Feb 27;16(2):e55100. doi: 10.7759/cureus.55100. eCollection 2024 Feb.
Currently, three monoclonal antibodies (MABs) have received regulatory approval from the federal agency, the United States Food and Drug Administration (USFDA), for the medical management of neuromyelitis optica spectrum disorder (NMOSD). Satralizumab was the third approved therapy after MABs like eculizumab and inebilizumab for NMOSD, an uncommon but severe enfeebling autoimmune neurological disease. Satralizumab, a humanized monoclonal antibody, exerts its action in NMOSD by acting against cytokine interleukin-6 (IL-6), a foremost mediator in the pathological process of NMOSD. Two pivotal clinical trials carried out in NMOSD patients had established that satralizumab significantly decreased the rate of relapse in patients suffering from NMOSD as opposed to placebo. The trials also demonstrated that satralizumab is relatively safe. Thus, satralizumab provides an efficacious and safe treatment option for this rare, disabling central nervous system (CNS) disease. Our review aimed to elucidate the pharmacological characteristics of satralizumab and illustrate the available evidence regarding its safety and efficacy in patients with NMOSD.
目前，三种单克隆抗体（MABs）已获得美国联邦机构美国食品药品监督管理局（USFDA）的监管批准，用于视神经脊髓炎谱系障碍（NMOSD）的药物治疗。萨特利珠单抗是继依库珠单抗和依奈利珠单抗等单克隆抗体之后，第三种被批准用于治疗NMOSD的药物，NMOSD是一种罕见但严重的使人衰弱的自身免疫性神经疾病。萨特利珠单抗是一种人源化单克隆抗体，通过作用于细胞因子白细胞介素-6（IL-6）发挥其在NMOSD中的作用，IL-6是NMOSD病理过程中的主要介质。在NMOSD患者中进行的两项关键临床试验证实，与安慰剂相比，萨特利珠单抗显著降低了NMOSD患者的复发率。试验还表明，萨特利珠单抗相对安全。因此，萨特利珠单抗为这种罕见的、使人致残的中枢神经系统（CNS）疾病提供了一种有效且安全的治疗选择。我们的综述旨在阐明萨特利珠单抗的药理学特性，并阐述其在NMOSD患者中的安全性和有效性的现有证据。
